Fluoxetine Tablets recalled over manufacturing violations
- Recall date
- May 27, 2025
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- Torrent Pharma Inc. recalls Fluoxetine Tablets, USP, 20 mg, 28-count Carton (4x7 Unit-dose), Manufactured by: TORRENT PHARMACEUTIALS LTD., Indrad-3…
- Recall number
- D-0456-2025
- FDA classification
- Class II
- Brand / firm
- Torrent Pharma Inc.
- Sold / distributed
- U.S. Nationwide.
Why it was recalled
CGMP Deviations: Presence of N-Nitroso Fluoxetine exceeding interim acceptable intake limit.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Fluoxetine Tablets, USP, 20 mg, 28-count Carton (4x7 Unit-dose), Manufactured by: TORRENT PHARMACEUTIALS LTD., Indrad-382 721 INDIA; Manufactured for: TORRENT PHARMA INC., Basking Ridge, NJ 07920. NDC: 13668-473-91 (Carton); 13668-473-70 (Blister)
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